• Cytel (Cambridge, Massachusetts) has reported the release of East 5, an advanced version of to clinical trial design and monitoring software system. The company says major advancements include expanded visualization tools for better understanding of trial design concepts amongst trial planners, clinical operations and regulators — new report-ready tables for protocol review and study results submission — better designs for trials using smaller sample sizes — more single-look trial designs and simulations. Cytel is a provider of clinical trial consulting services, statistical software, and outsourced clinical study reports for the biopharma, medical device, academic and research institute markets.
•FEI (Hillsboro Oregon) reported the next generation of its popular Vitrobot cryo sample preparation tool, the Vitrobot Mark IV, calling it an easy-to-use system that features a newly-designed touchscreen operated under a Linux operating system and robotics that ensures reproducible freezing of samples. Beyond biological applications, the Vitrobot Mark IV can also be used for pharmaceutical, food and general industrial applications where colloidal structures need to be characterized and analyzed. FEI provides instruments for nanoscale imaging, analysis and prototyping.
•Nonin Medical (Minneapolis) reported FDA clearance of the LifeSense capnograph/pulse oximeter that combines capnography and pulse oximetry into one device. Key features of the oximeter are its Widescreen LCD display, portability and light weight. The LifeSense capnograph comes equipped with Nonin's PureSAT technology, designed to enable accurate readings and rapid response time. The LifeSense is used in settings such as acute care, emergency medical services, intensive care units and during procedural sedation. Nonin also offers this capnography (EtCO2) technology to OEM (original equipment manufacturers) with the MaCO2 board.
•Sciton (Palo Alto) reported that the ProLipo laser module received FDA clearance for laser-assisted lipolysis and its BBL broadband pulsed light received clearance for the treatment of wrinkles. ProLipo module, physicians will be able to offer patients a minimally invasive treatment that ablates and liquefies fat deposits in treated areas. ProLipo will ideally be used in combination therapy with other proprietary treatments developed by Sciton. The end result is skin thatappears firm, toned and smooth. As a stand-alone procedure or in combination with liposuction, ProLipo can be performed under local anesthesia with less downtime and recovery than traditional lipolysis. Sciton develops laser and light source solutions for medical professionals.
•Smiths Medical (ST. Paul, Minnesota) reported the expansion of its spinal anesthesia tray product line to include needle protection safety devices, providing anesthesiologists and infection control customers with increased product configurations and a complete line of spinal anesthesia trays available from one source. Smiths Medical has increased their line of standard spinal anesthesia trays from two to nine. The Point-Lok device is a product that can be used on a variety of needle types and sizes, and helps provide protection for needles from 16 – 30 gauge. Smiths Medical develops safety, critical care/medication delivery, and patient monitoring devices.